体外循环心脏直视手术中负压调节器辅助静脉引流的随机对照试验  

Vacuum-assisted venous drainage in adult open-heart surgery:A randomized controlled trial

作　　者：刘刚 高思哲 王建 周纯 闫姝洁 王茜 滕媛 刘燕[2] 陈彧[3] 吉冰洋 LIU Gang;GAO Sizhe;WANG Jian;ZHOU Chun;YAN Shujie;WANG Qian;TENG Yuan;LIU Yan;CHEN Yu;JI Bingyang(Department of Cardiopulmonary Bypass,Fuwai Hospital,Chinese Academy of Medical Science and Peking Union Medical College,Beijing,100037,P.R.China;Department of Cardiopulmonary Bypass,Wuhan Asia Heart Hospital,Wuhan,430022,P.R.China;Department of Cardiac Surgery,Peking University People’s Hospital,Beijing,100044,P.R.China)

机构地区：[1]中国医学科学院阜外医院体外循环中心,北京100037 [2]武汉亚洲心脏病医院体外循环科,武汉430022 [3]北京大学人民医院心脏中心,北京100044

出　　处：《中国胸心血管外科临床杂志》2022年第11期1460-1465,共6页Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

摘　　要：目的评估负压调节器辅助静脉引流在体外循环心脏直视手术中的安全性和有效性。方法入选2017年11月17日—2018年10月1日3个中心的180例患者,按照1∶1比例随机分配到负压辅助静脉引流组(VAVD组)和重力引流组(GD组)。在心脏直视手术体外循环过程中时,VAVD组完全依赖负压控制器实现静脉引流,GD组采用常规重力引流。主要研究终点为在体外循环开始降温时、主动脉阻断15 min后、复温至鼻咽温36℃时动脉管流量。次要有效性终点包括红细胞压积、血红蛋白浓度、血制品输注等。安全性终点包括游离血红蛋白浓度等。结果最终本试验全分析集共175例患者,其中VAVD组87例、GD组88例。VAVD组患者年龄(52.8±12.0)岁,男性占比55.2%;GD组患者年龄(51.4±12.1)岁,男性占比59.1%。两组人口学特征差异无统计学意义。在体外循环转流中,应用负压辅助静脉引流可以提供的动脉灌注流量与常规重力引流相比差异无统计学意义[3次时间点均数:(2.37±0.22)L/(min·m^(2))vs.(2.41±0.25)L/(min·m^(2)),P=0.271],同时,VAVD并未引起游离血红蛋白浓度升高。结论体外循环下心脏直视手术应用负压调节器可以得到有效的静脉引流,同时,不升高游离血红蛋白浓度,不加重血液破坏。Objective To analyze the safety and efficacy of vacuum-assisted venous drainage(VAVD)in cardiac surgery under cardiopulmonary bypass(CPB).Methods A total of 180 patients from 3 centers between November 17,2017 and October 1,2018 were enrolled and randomly assigned to a VAVD group and a gravity drainage(GD)group by 1∶1 ratio.During the open-heart surgery under CPB,the VAVD group completely relied on VAVD,and the GD group used conventional GD.The primary endpoint was arterial flow before CPB,15 min after aortic cross-clamping and rewarming to 36°C of nasopharyngeal temperature.The secondary endpoints included hematocrit,hemoglobin concentration,blood product transfusion,etc.The safety endpoint was free hemoglobin concentration,etc.Results The full analysis set contained 175 patients,87 in the VAVD group and 88 in the GD group.Patients in the VAVD group were aged 52.8±12.0 years,and males accounted for 55.2%;patients in the GD group were aged 51.4±12.1 years,and males accounted for 59.1%.The demographic characteristics between the two groups were not statistically different.Compared to the GD group,the VAVD group could provide comparable arterial flow in CPB[average of 3 time points,2.37±0.22 L/(min·m~2)vs.2.41±0.25 L/(min·m^(2)),P=0.271],while not elevating free hemoglobin concentration.Conclusion VAVD can provide enough venous drainage,while not elevating free hemoglobin concentration or damaging blood.

关 键 词：体外循环 负压辅助静脉引流 心脏手术 随机对照试验 

分 类 号：R654.2[医药卫生—外科学]